Durability of Mitral Valve Surgery: Repair, Replacement or ......Circle Low Leaflet Stress Areas of...

Christoph Huber, CCV HUG 2016

Durability of Mitral Valve Surgery: Repair, Replacement or

simply a clip?

Christoph Huber

Chirurgie Cardio Vasculaire

HUG



La chirurgie cardiaque innovatrice et durable


Mitral valve disease

• Mitral regurgitation in 1.7% of the population,

• 56% of individuals with congestive heart failure.

• MR is a major cause of heart failure and disability.1

• Severe MR compromises left ventricular function,

induces pulmonary hypertension, alters heart

architecture and predisposes to atrial fibrillation.2

1. Nkomo VT, Gardin JM, Skelton TN. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368:1005-1011.

2. McCarthy KP, Ring L, Rana B. Anatomy of the mitral valve: understanding the mitral valve complex in mitral regurgitation.Eur J Echocardiogr. 2010;11:i3-i9.ar heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11.


Prevalence of mitral valve disease

• > 70 years increased prevalence of 5.5% 1

• MR second most frequently operated valve

disease2

• Can remain asymptomatic

• Severe MR most likely becomes symptomatic

after 6 years

1. Singh JP, Evans JC, Levy D, et al. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the FraminghamHeart Study) Am J Cardiol. 1999;83(6):897–902.

2. Lee EM, Porter JN, Shapiro LM, et al. Mitral valve surgery in the elderly. Journal of Heart Valve Disease. 1997;6(1):22–31.


Prevalence of mitral valve disease

Prevalence of mitral and aortic valve disease 60-70y 2.3%, >70 5.5%

Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-basedstudy. Lancet. 2006 Sep 16;368(9540):1005-11.


Paradigm shift in mitral surgery ?

Repair

Repair

ReplacementReplacement

Acker MA et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014 Jan 2;370(1):23-32.

2014






Repair

Replacement


2014

-No significant outcome difference between repair and replacement in regards of remodelling and survival

Replacement is more durable


Paradigm shift in mitral surgery ? Is it new?

De Bonis M et al. Mitral replacement or repair for functional mitral regurgitation in dilated and ischemic cardiomyopathy: is it really the same? Ann Thorac Surg. 2012;94(1):44–51.

Repair better than replacement

Gillinov AM et al. Repair versus replacement for degenerative mitral valve disease with coexisting ischemic heart disease. J Thorac Cardiovasc Surg. 2003;125(6):1350–1362.

Repair = replacement

Acker MA et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014;370(1):23–32.

Replacement better than repair


Mitral valve

Drawing from Walt Disney for Ch. Bailey 1946


Structural vs functional = Primary vs secondary

In primary MR, the valvular incompetence is caused by compromised or structurally disrupted components of the valve apparatus

in functional (secondary) MR the valve is structurally normal, with the regurgitation resulting from failure of coaptation of the mitral valve leaflets without coexisting structural changes of the valve itself.



normal Primary structural Primary structural Secondary functional



Structural/primary

Functional / secondary


Badhwar, Bolling , chapter in: Advances in Heart Failure, 2004

Geometric MR in Dilated Cardiomyopathy

“loss of closure cylinder”


Geometric MR in Ischemia

Badhwar, Bolling , chapter in: Advances in Heart Failure, 2004



„Functional mitral regurgitation is a common clinical entity which will likely increase in the future due to predicted demographic changes. It is also associated with poor long-term survival.


Nishimura RA; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132.


One fits all vs. tailored treatments options







Durability of surgical mitral valve


Freedom from SVD > 60y

Bourguignon T et al.. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 50-65 years. Eur J Cardiothorac Surg. 2016 May;49(5):1462-8.


Bourguignon T et al.. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 50-65 years. Eur J Cardiothorac Surg. 2016 May;49(5):1462-8.

CONCLUSIONS: In patients aged 50–65 years undergoing AVR with the Carpentier-Edwards Perimount bioprosthesis, the expected valve durabilitywas 19 years. Age was not a significant risk factor for SVD within this agegroup. Patient selection and attention to timing of reinter- vention may bedeterminants of long-term outcomes.

Freedom from SVD 50 – 65y


Mitral valve durability

Bourguignon T, et al. Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25-year follow-up of 450 implantations. J Thorac Cardiovasc Surg. 2014 Nov;148(5):2004-2011.e1.

Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25-year follow-up of 450 implantations.

The expected valve durability was 16.6 years for the entire cohort (11.4, 16.6, and 19.4 years for patients aged <60, 60 to 70, and >70 years, respectively


Durability of surgical mitral valves

Gabriel Loor et al. The Carpentier-Edwards Perimount Magna mitral valve bioprosthesis: intermediate-term efficacy and durability. J Cardiothorac Surg. 2016; 11: 20.

From 2008 through 2011 (our 4-year study period), 70 Magna valves were implanted in the mitral position at a single institution (the Cleveland Clinic) - Thermofix

90 % of patients were free from significant structural valve degeneration at 5 years


*No clinical data are available which evaluate the long-term impact of the Edwards Lifesciences tissue treatment in patients.

Schoen FJ, Levy RJ. Tissue heart valves: current challenges and future research perspectives. J Biomed Mater Res.

1. Intrinsic cuspal calcification can be prevented or delayed by calcium mitigant treatment

2. Structural degeneration due to stress can be prevented or delayed by tissue selection, leaflet design and valve circularity

Factors leading to calcification


None (Glutaraldehyde Fixation)

Only one binding site addressed

Both binding sites addressed (Residual glut. & Phospholipids)

Degree of Anti-Calcification

Edwards SAPIEN XT THV

St Jude Portico

Medtronic CoreValve

Medtronic CoreValve Evolut

SymetisAcurate TA

Medtronic Engager

JenaValveTA

Medtronic Engager

DirectFlowTF

Comparison of anti-calcification treatments



Durability

EllipseHigher Leaflet Stress

CircleLow Leaflet Stress

Areas of high stress can induce collagen degeneration that over time could lead to tearing and valve failure1

Valve designs that reduce leaflet stresses “are likely to have improved performance in long-term applications”2

1.Schoen Frederick J. Cardiac Valve Prostheses: Pathological and Bioengineering Considerations. J Cardiac Surg. 1987;2:65-108. 2.Sun W., Li K., Sirois E. Simulated elliptical bioprosthetic valve deformation: Implications for asymmetric transcatheter valve deployment. J Biomech. 2010;43:3085-3090.


Circularity at the annulus maximizes area and flow to minimize load on the left ventricle


Principles Surgical and

transcatheter aortic valve

Predictable procedure

Optimal hemodynamics

Low rate of complications

Durability

(1) Harken DF, et al. Aortic valve replacement with a caged ball

valve. Am J Cardiol 1962;9:292-299.

The principles of aortic valve replacement

have not changed since 1962(1)


The Alfieri stitch – the double orifice valve

Maisano F … Alfieri O. The edge-to-edge technique: a simplified method to correct mitral insufficiency. Eur J Cardiothorac Surg 1998;13(3):240-5.


Mitraclip


Accelerated Development of TAVI devices


Current CE Mark Approved Devices*

Sadra Medical Lotus

SymetisACCURATE TA

EdwardsSAPIEN 3

St. Jude Portico Direct Flow Medical

*As of 2014

JenaValve

EdwardsSAPIEN XT

Medtronic CoreValve

Medtronic Engager


DEVICES PENDING CE MARK APPROVAL

Edwards CENTERA

Medtronic Evolut R

SymetisACCURATE TF

Colibri Heart Valve

Heart LeafletTechnology

NVT Allegra

JenaValve Plus

Trinity Valve



Transcatheter mitral valve replacement

Edwards FORTIS

Tendyn Twelve

Tiara Edwards CardiAQ


Transcatheter mitral valve replacement 2014

2014


Five transcatheter mitral valve systems implanted in humans: CardiAQ valve system (CardiAQ Valve Technologies, Inc.)Tiara™ valve (Neovasc Inc., Richmond, Canada); FORTIS valve (Edwards Lifesciences, Irvine, CA, USA); Tendyne valve (Tendyne Inc., Roseville, MN, USA); Twelve valve (Twelve, Inc., Redwood City, CA, USA).

Common features: Nitinol self-expanding frames, Trileaflet valves, Bovine pericardial leaflets (Tendyne porcine), Fabric sealing skirt (CardiAQ is pericardial)Transapical delivery (CardiAQ also transseptal)

Transcatheter mitral valve replacement


Transcatheter mitral valve replacement - Limitations


CardiAQ

(A) The valve consists of a self-expandingnitinol frame that carries 3 leaflets of bovine pericardial tissue. Implantation sequence of CardiAQ valve: ( B ) coaxial align- ment, ( C ) opening of the ventricular anchors, ( D ) opening of the atrial anchors, and ( E ) final release of the CardiAQ valve before removalthe delivery system. F , Left ventriculogram.


Tiara valve

The D-shape of the valve, with atrial skirtand saddle-shaped valve. B , Transapical 32F delivery system. Implantation sequence ( C ) the coronary sinus wireoutlines the mitral annulus; deliverysystem is through the mitral annulus intothe left atrium; ( D ) opening of the atrial ( E ) the atrial skirt is open ( F ) final release of the Tiara valve, before removalof the delivery system.


Tendyn

Self-expanding metal alloy frame made of an inner stent containing a trileafletporcine pericardial valve and an outerstent. ( B ) access of left atrium withdilator and sheath; ( C ) advancement of valve within sheath, deploying valve in leftatrium; tether traction is used to position the valve in native annulus; ( D ) the polymer tether allows the valve to becaptured for repositioning


Endovalve

The Endovalve system is a foldablenitinol structure that is designed to conform to the mitral annulus and attaches to the native valve withspecially designed grippers


HighLife transcatheter mitral


Neocord transapical


Coronary sinus devices Carillion Monarc Coapsys

Progressive design concepts in off-pump left ventricular remodeling mitral valve repair devices. David W. Yaffee et al. Ann Cardiothorac Surg. 2015 July; 4(4): 352–354.


Percutaneous Annuloplasty devices Cardioband

Mitralign


Durabilité


Durabilité


Easy to get in but more difficult to get out


Sélection des patients



Durability of Mitral Valve Surgery: Repair, Replacement or

simply a clip?

Christoph Huber

Chirurgie Cardio Vasculaire

HUG

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